Amlodipine Besylate
Amlodipine Besylate Tablets
Approved
Approval ID
5b1e1926-d2d4-8bb1-185c-f0da07247b51
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 31, 2007
Manufacturers
FDA
Dr Reddy's Laboratories
DUNS: 862179079
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Amlodipine Besylate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code55111-270
Application NumberANDA076692
Product Classification
M
Marketing Category
C73584
G
Generic Name
Amlodipine Besylate
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 4, 2010
FDA Product Classification
INGREDIENTS (5)
Amlodipine BesylateActive
Quantity: 5 mg in 1 1
Code: 864V2Q084H
Classification: ACTIB
colloidal silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
cellulose, microcrystallineInactive
Code: OP1R32D61U
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
sodium starch glycolate type A potatoInactive
Code: 5856J3G2A2
Classification: IACT
Amlodipine Besylate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code55111-269
Application NumberANDA076692
Product Classification
M
Marketing Category
C73584
G
Generic Name
Amlodipine Besylate
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 4, 2010
FDA Product Classification
INGREDIENTS (5)
Amlodipine BesylateActive
Quantity: 2.5 mg in 1 1
Code: 864V2Q084H
Classification: ACTIB
colloidal silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
cellulose, microcrystallineInactive
Code: OP1R32D61U
Classification: IACT
sodium starch glycolate type A potatoInactive
Code: 5856J3G2A2
Classification: IACT
Amlodipine Besylate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code55111-271
Application NumberANDA076692
Product Classification
M
Marketing Category
C73584
G
Generic Name
Amlodipine Besylate
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 4, 2010
FDA Product Classification
INGREDIENTS (5)
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
Amlodipine BesylateActive
Quantity: 10 mg in 1 1
Code: 864V2Q084H
Classification: ACTIB
cellulose, microcrystallineInactive
Code: OP1R32D61U
Classification: IACT
colloidal silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
sodium starch glycolate type A potatoInactive
Code: 5856J3G2A2
Classification: IACT